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Guidelines
for Assessing Training Competency Levels
In general, the
regulations require each person to have an appropriate education,
training, and experience to perform their assigned functions.
Part one of the series
(published by Journal of cGMP Compliance, Volume 1, Number 3, January
1998) gave an overview of cGMP training and discussed issues including:
How should employees be trained to perform tasks? Competencies
assessed? And skills maintained? How should training be recorded and
tracked?
The Code of Federal
Regulations (CFR) section 211.25 describes the basic requirements of
personnel qualifications necessary to comply with the regulations. In
general, the regulations require each person to have appropriate
education, training, and experience to perform their assigned
functions. The cGMP training must be performed by qualified individuals
on a continuing basis and with sufficient frequency to assure that
employees remain familiar with requirements applicable to them.
Persons in a supervisory role must not only fulfill the general
requirements above, but their function should also provide “assurance
that the drug product has the safety, identity, strength quality and
purity that it purports or is represented to possess”. The regulations
provide further clarification in that there must also be an “adequate
number of qualified personnel to perform and supervise” the operations.
As with any section of
the CFR, the directives as to what is adequate and the definition of
qualified, trained, and experienced are equally open to interpretation.
Providing sufficient documented evidence that a person adequately meets
these requirements for their individual responsibilities within the
entire manufacturing, packaging, labeling, testing, final release,
etc.) is complicated. Competence has been defined (Webster’s Collegiate
Dictionary, 10th edition) as “having requisite or adequate ability,”
and this can arguably be applied to regulatory requirements. Defining
competency can be as equally difficult as defining adequately educated,
trained and experienced. A person may have gone through the latter and,
therefore, potentially is considered acceptable to perform an
operation, i.e., they ostensibly have the technical knowledge. However,
as an individual they may not possess the ability to transfer the
theory into practice and thus their unsupervised involvement in a
process would be unacceptable. In other words, competence also needs to
be assessed in the practical performance of processes.
The operational
competencies of staff may be considered and structured in a similar way
to career development models. One such model has four (4) competency
levels:
- A learning-dependent level requiring supervision
(training).
- A trained level (qualified and work independently).
- A skilled level (interact with external groups).
- An expert level (develops operational strategies).
Each level may be
subdivided to recognize progress through the levels; for example, early
and late phases.
For more information
contact RCS, Inc.
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